title: Gothenburg very early supported discharge study (GOTVED) NCT01622205: a block randomized trial with superiority design of very early supported discharge for patients with stroke.
abstract: BACKGROUND
  Stroke is the disease with the highest costs for hospital care and also after discharge. Early supported discharge (ESD) has shown to be efficient and safe and the best results with well-organised discharge teams and patients with less severe strokes. The aim is to investigate if very early supported discharge (VESD) for stroke patients in need for on-going individualised rehabilitation at home is useful for the patient and cost effective.
  
  
  METHODS
  A randomized controlled trial comparing VESD with ordinary discharge.
  
  
  METHODS
  confirmed stroke, >18 years of age, living within 30 min from the stroke unit, on day 2 0-16 points on the National institute of health stroke scale (NIHSS) and 50-100 points on the Barthel Index (BI), with BI 100 then the patient can be included if the Montreal Cognitive Assessment is < 26. Exclusion criteria are: NIHSS >16, BI < 50, life expectancy < 1 year, inability to speak or to communicate in Swedish. The inclusion occurs on day 4 and in block randomization of 20 and with blinded assessor.
  
  
  METHODS
  levels of anxiety and depression.
  
  
  RESULTS
  independence, security, level of function, quality of health, needs of support in activities of daily living and caregiver burden. Power calculation is based on the level of anxiety and with a power of 80%, p-value 0.05 (2 sided test) 44 persons per group are needed. Data is gathered on co-morbidity, re-entry to hospital, mortality and a health economic analysis. Interviews will be accomplished with a strategic sample of 15 patients in the intervention group before discharge, within two weeks after homecoming and 3 months later. Interviews are also planned with 15 relatives in the intervention group 3 months after discharge.
  
  
  CONCLUSIONS
  The ESD studies in the Cochrane review present hospital stays of a length that no longer exist in Sweden. There is not yet, to our knowledge, any study of early supported discharge with present length of hospital stay. Thus it is not clear if home rehabilitation nowadays without risks, is cost effective, or with the same patient usefulness as earlier studies.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01622205.
authors.affiliation: Institute of Neuroscience and Physiology, Rehabilitation Medicine, University of Gothenburg, Gothenburg, Sweden. ks.sunnerhagen@neuro.gu.se
authors.forename: Katharina S
authors.initials: KS
authors.lastname: Sunnerhagen
authors.forename: Anna
authors.initials: A
authors.lastname: Danielsson
authors.forename: Lena
authors.initials: L
authors.lastname: Rafsten
authors.forename: Ann
authors.initials: A
authors.lastname: Björkdahl
authors.forename: Åsa B
authors.initials: ÅB
authors.lastname: Axelsson
authors.forename: Åsa
authors.initials: Å
authors.lastname: Nordin
authors.forename: Cathrine A
authors.initials: CA
authors.lastname: Petersson
authors.forename: Åsa
authors.initials: Å
authors.lastname: Lundgren-Nilsson
authors.forename: Karin
authors.initials: K
authors.lastname: Fröjd
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001007:Anxiety / Q000209:etiology; D003362:Cost-Benefit Analysis; D003863:Depression / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D010351:Patient Discharge; D020521:Stroke / Q000191:economics / Q000523:psychology*; D000071939:Stroke Rehabilitation; D011795:Surveys and Questionnaires; D013548:Sweden / Q000453:epidemiology; D013997:Time Factors; D055815:Young Adult